Device and method for delivering grafts

ABSTRACT

A device and method for delivering a graft or synthetic mesh for anatomical repair to the repair site, with the graft or synthetic mesh in position for attachment to repair the defect. A plurality of spaced apart, flexible fingers is connected to the graft or synthetic mesh. The flexible fingers are initially in a position that is generally parallel to a direction of travel of the actuator. The actuator moves the plurality of flexible fingers from the initial to form a radial array, which opens or extends the graft or synthetic mesh. The graft or synthetic mesh may then be attached. A novel trocar is disclosed that is useful with the device. A measuring device including a measuring scale that is useful for determining the required size of the graft is also disclosed.

Applicant claims the benefit of U.S. Provisional Application Ser. Nos.61/573,587 filed Sep. 8, 2011; 61/571,857, filed Jul. 7, 2011;61/550,600, filed Oct. 24, 2011 and 61/563,321, filed Nov. 23, 2011.

FIELD OF THE INVENTION

This invention relates to medical devices and methods generally, and ismore specifically related to a device and method of delivering a graftfor attachment to tissue.

BACKGROUND OF THE INVENTION

Biological grafts and synthetic mesh are used to repair anatomicaldefects, such as hernias. Delivery of the mesh or graft into bodycavities either requires invasive surgery, or heretofore unsatisfactorylaparoscopic methods.

Hernias are structural defects most commonly involving themusculofascial tissues of the abdominal and pelvic regions within thehuman body. Some hernias involve internal muscular defects (i.e.,diaphragmatic, hiatal hernias) while most involve the abdominal wall.Common types of abdominal wall hernias include inguinal, femoral,umbilical, ventral and incisional hernias. Unless they are completelywithout associated symptoms, most hernias eventually require surgicalrepair. Some of the common hernia symptoms include activity-inducedpain, uncomfortable visible bulges, alteration in bowel function, andincarcerated or strangulated internal organs within the hernia resultingin emergent surgical intervention.

It is estimated that approximately 800,000 to 900,000 hernia operationsare performed annually in the United States of which 200,000 involveventral variety. Ventral hernias may be primary hernias (i.e.,epigastric, Spiegelian hernias) but most commonly are incisional typeswhich sometimes form after surgical incisions are made through theabdominal wall for the purpose of gaining access into the internalorgans for various operations.

Surgical repair of ventral incisional hernias may be accomplished via an“open method.” This method involves making a sizable incision directlyover the tissue defect, separating the contents of the hernia away fromthe musculofascial defect, and repairing the defect primarily usingsutures, or more commonly, sewing a graft to the defect edge intension-free manner. This is done in an effort to minimize therecurrence of hernia formation which, unfortunately, occurs with somefrequency. The recurrence may be due to multiple factors includinggeneral health of the patient, surgical technique, and types of mesh orgraft utilized. Overall, this traditional method is effective, but alsooften involves more pain, longer periods of disability following thesurgery, higher perioperative infection rates, and an established herniarecurrence rate.

Alternatively, ventral incisional hernias may be repaired using the“laparoscopic method.” This method utilizes endoscopic or laparoscopicapproach in which multiple tiny incisions are made remote from themusculofascial defect, trocars placed through these small incisions foraccess to the internal abdomen, internal organs or tissues separatedfrom the hernia defect, a mesh or graft delivered through the trocar insome fashion, mesh or graft positioned over the defect and finally,graft or mesh secured around the defect with sutures and/or variousfixation devices. This method is advantageous over the “open method” dueto lesser surgical pain, shorter period of disability following surgery,lower infection rate and perhaps lower hernia recurrence rate. However,these perceived benefits are subject to vigorous debate within thesurgical community.

Currently, approximately 30 to 40 percent of ventral incisional herniasare repaired using the laparoscopic method. However, this method has itsown set of major shortcomings principally related to higher degree ofdifficulty in performing this procedure. One of the major challengesinvolve graft introduction into the abdominal cavity. Typically, a graftis rolled tightly into a cylindrical configuration and subsequently,pushed/pulled through the trocar which can be both time consuming andfrustrating, especially when a larger graft is needed to cover thedefect. This maneuver can also damage the graft during the delivery dueto excessive force used or needed during the delivery process. Somesurgeons also elect to place multiple sutures within the periphery ofthe graft for transfascial securement. This is often done prior tointroduction of the graft. Once delivered into the abdominal cavity, therolled graft/suture combination is unrolled, sutures isolated intorespective corresponding abdominal quadrants, and the graft is centeredover the defect prior to fixation. These steps are often verychallenging and frustrating to accomplish in an efficient manner due tothe pliable property of the graft and sutures which is a desiredcharacteristic.

In addition, due to the change in concavity of the inner abdominal wallwithin versus the outer skin surface, correct sizing of the mesh orgraft is compromised. This situation leads to an overestimation of theneeded mesh or graft size, leading to further difficulties. Theseshortcomings contribute to a reason that laparoscopic methods, despiteadvantages, are less commonly utilized by many surgeons at the presenttime.

There is a need for a device and method that overcomes the deficienciesof current endoscopic or laparoscopic procedures, such as those used forventral hernia repair. This new surgical device allows precise yeteffortless delivery of a larger prosthetic mesh or graft via a noveltrocar design for subsequent graft fixation. It also allows for moreprecise sizing of the defect thus eliminating a major frustration oftenencountered when working with a large piece of mesh or graft.

SUMMARY OF THE INVENTION

The present invention is a device and method for delivering a syntheticmesh or graft for anatomical repair at the defect site, with thesynthetic mesh or graft in position for attachment to repair the defect.A plurality of spaced apart, flexible fingers is connected to thesynthetic mesh or graft. The flexible fingers are initially in aposition that is generally parallel to a direction of travel of theactuator. The actuator moves the plurality of flexible fingers from theinitial position to form a radial array, which opens or extends thesynthetic mesh or graft. The synthetic mesh or graft may then be securedin place.

A novel trocar is disclosed that is useful with the device. The lengthof the trocar is variable. Components for retaining the trocar inposition for use with the delivery device are provided. A measuringdevice including a measuring scale that is useful for determining therequired size of the graft is also disclosed.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a sectioned view of an embodiment of a device for delivery ofa graft for attachment to tissue.

FIG. 2a is a partial, sectioned view of the device for delivery of agraft for attachment to tissue as shown in FIG. 1.

FIG. 2b is a partial, sectioned view of another embodiment of the devicefor delivery of a graft for attachment to tissue as shown in FIG. 1.

FIG. 3 is a sectioned view of the device for delivery of synthetic agraft to tissue as shown in FIG. 1, with the graft in an extended oropen position.

FIG. 4 is a partial, sectioned view of the device for delivery of agraft for attachment to tissue as shown in FIG. 3.

FIG. 5, FIG. 6 and FIG. 7 show progressive attachment of a graft forattachment to tissue according to an embodiment of the device.

FIG. 8 demonstrates deployment of the graft for attachment to tissuethrough a trocar according to an embodiment of the device.

FIG. 9 demonstrates the graft for attachment to tissue as deployed by anembodiment of the device.

FIG. 10, FIG. 11 and FIG. 12 show progressive attachment of the graftattachment to tissue according to an embodiment of the device.

FIG. 13 is a perspective view of a novel trocar that is useful with thedelivery device.

FIG. 14a is a sectioned view of the novel trocar.

FIG. 14b is an exploded view of the novel trocar of FIG. 14 a.

FIG. 15 is an elevation of the novel trocar.

FIG. 16 is an exploded view of the novel trocar.

FIG. 17 is an elevation of the measuring device.

FIG. 18 is a sectioned view demonstrating use of the novel trocar andmeasuring device in situ in a ventral hernia.

FIG. 19 is a sectioned view demonstrating use of the delivery device insitu in a ventral hernia.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Turning now to the drawing figures, FIG. 1 shows an embodiment of adelivery device for delivery of a graft or synthetic mesh 2 forattachment to tissue. The term “graft” is used herein to indicate eithera graft formed of biological material, or a synthetic mesh. The graft isconnected to a plurality of flexible fingers 4. The flexible fingers andgraft, when positioned as shown in FIG. 1, may be present within asheath 6. The flexible fingers are generally parallel to a central axisof the sheath, and generally parallel to an axis of travel of anactuator 8. Since the fingers are flexible, some bending of the fingersmeans that they may not be strictly parallel, but are generallyparallel, to the axis of travel of the actuator while held in theposition shown in FIG. 1 or FIG. 2.

FIG. 1 and FIG. 2 show the device for delivery of graft for attachmentto tissue, according to an embodiment, prior to deployment of the graft.FIG. 3 shows the same embodiment of the device with the graft deployed.In this embodiment, the actuator pushes the flexible fingers outwardly.The flexible fingers of this embodiment are attached to, and move with,the actuator. The actuator moves outwardly away from the handle asdemonstrated in FIG. 3, causing the flexible fingers to also moveoutwardly and away from the handle.

A plurality of control wires 10 may be attached to the handle, or tosome stationary article associated with the handle (such as rod 12), atan end of the control wires that is proximal to the handle. The controlwires are fixed to a point on the device so that they do not move as theactuator and flexible fingers move, so that the control wires will pullagainst the flexible fingers as the flexible fingers move outwardly andaway from the handle. The control wires are connected to the flexiblefingers at or near a distal end of the control wires. In a preferredembodiment, each of the plurality of control wires is associated withone of the plurality of the flexible fingers. Since the control wiresare fixed at the proximal end and attached at the distal end to a pointon the flexible fingers, while the flexible fingers are movable with theactuator, the control wires pull against the flexible fingers at thepoint of attachment as the flexible fingers move outwardly. The controlwires are preferred to be nitinol wires, but the control wires could beformed of other metals, or plastics, textile materials or polymers, orsimilar materials having sufficient strength and flexibility.

The control wires are fixed to the flexible fingers at a point that willprovide the required arcuate travel of the flexible fingers as thedevice is actuated. This point of attachment may be spaced apart fromthe point of bending of the flexible fingers, and may be less than 25%of distance along the length of flexible fingers, as measured from thejoinder of the flexible fingers to the holder and/or actuator to thedistal end of the flexible fingers. FIG. 4. As shown, the control wiresform a 30° to 60° degree angle relative to the flexible fingers when theactuator is fully advanced.

As used herein, “proximal” is closest to the operator of the device, and“distal” will typically be away from the operator, and toward thepatient when the device is in use.

As demonstrated by FIG. 4, as the actuator moves outwardly and away fromthe handle, it pushes the flexible fingers outwardly. The control wires,being fixed, pull against the flexible fingers, moving the flexiblefingers to a downward position as shown in FIG. 3 and FIG. 4. As theflexible fingers move downward, they form a radial array (FIG. 9) andunfold the graft to a generally planar position. In a preferredembodiment, the flexible fingers, as they are moved by the actuator andpulled down by the control wires, move past a position that isperpendicular to the axis of travel of the actuator, as shown in FIG. 3and FIG. 4. In a preferred embodiment, when the travel of the actuatoris fully exhausted and the actuator is in its most outward and distalposition relative to the handle, the flexible fingers will be positionedat an angle of more than 90° from the axis of travel of the actuator, orthe central axis of the sheath. In some embodiments, this angle could beup to 120°. The actuator may be designed to allow the operator to setthe desired angle. In some embodiments then, the angle may be at least100° and perhaps more, so that the edges, or periphery, of the graft arepulled against the defect of the patient for subsequent securing orsuturing of the graft as shown in FIG. 9.

According to one embodiment of the invention as shown in FIG. 1 to FIG.4, the device may comprise a pistol grip handle 14 having a trigger 16.The handle may form housing for the mechanism, including the actuator.The trigger pivots relative to the handle, and the trigger may comprisea gear 18 at the top of the trigger. The gear of the trigger engages agear, such as a rack 20, which causes the actuator 8 to be advancedoutwardly or retracted inwardly, and the movement may be linear. In thisembodiment, the actuator slidably engages the housing 22 which forms thehandle, and projects from the muzzle 24 of the handle, as can be seenwhen comparing the position of the trigger and actuator relative to thehandle and muzzle in FIG. 1 with the position of the trigger andactuator relative to the handle and muzzle in FIG. 3.

At the distal end of the actuator, and preferably, externally to themuzzle of the housing, is the plurality of spaced-apart flexiblefingers. These fingers may be attached to a holder 26. The holder may inturn be attached to the actuator, so that the flexible fingers areadvanced and retracted by the actuator as it moves. The fingers may bemounted within the holder so as to be rotatable relative to the holder.Rotating the fingers relative to the actuator allows the spacing of thefingers to be modified if desired or necessary.

The flexible fingers are preferred to be formed of a flexible cable. Thecable may be a hollow cable formed of coiled or spirally-wound materialwhich is capable of repetitive flexing and bending. The cable maycomprise stainless steel. This property of flexing and bending isnecessary so that the cables can move outwardly relative to the handleand out of the sheath as shown in FIG. 1 and FIG. 2, and extenddownwardly to the position shown in FIG. 3 and FIG. 4. Since the cablesare subsequently retracted into the sheath by reversing the travel ofthe actuator by movement of the trigger from the position shown in FIG.3 to the position shown in FIG. 1, the cables must also be sufficientlyflexible to “snake” back into the sheath after detachment from the graftwithout disturbing the graft that is secured to tissue. The cables arepreferred to be fully flexible along their length, without havingpreformed bends or angles that may tend to dictate a path of travel asthe flexible fingers are withdrawn from the surgical site. The flexiblecables used with the control wires allow the cables to follow theanatomical structure or host tissue as a path of travel as the cablesare pulled away from the graft and toward the handle. Rigid members,rather than flexible cables, will resist removal, due to the anatomicalstructure or host tissue interfering with the path of travel.

In one embodiment, the flexible fingers are attenuated or weakened atintervals. This allows the operator to break of portions of the flexiblefingers to more precisely match the length of the fingers with the sizeof the graft that is selected. The intervals may be spaced, for example,1 cm apart, so that the length of the fingers may be reduced in 1 cmsteps. In another embodiment, the length of the flexible fingers isvaried by extending or retracting the flexible fingers relative to thedevice.

Movement of the flexible fingers from the position generally shown inFIG. 2 to the position shown in FIG. 4, which requires a movementthrough an arc, demonstrated by FIG. 4. This movement is accomplished bythe resistive force applied to the cables by the control wires. Theposition of the control wires relative to the handle and the flexiblefingers is fixed. That is to say, the control wires are attached at theproximal end to the handle, and not to the moving actuator. As theflexible cables move from the position of FIG. 1 to the position of FIG.3, there is sufficient slack in the control wires to allow outwardmovement of the flexible fingers from the sheath, but only to a limitingpoint. The length of the control wires is such that as the flexiblefingers move outwardly, the control wire attached to its associatedflexible finger at a fixed point becomes taught, and exerts force on theflexible finger, pulling the flexible finger back toward the handle. Inthis embodiment, when travel of the actuator, and the flexible fingers,is exhausted, the flexible fingers, and the graft attached thereto, isin the position shown in FIG. 4. As further demonstrated by FIG. 9, theflexible fingers, form a radial array. There may be as few as four (4)flexible fingers, and as many as eight (8) flexible fingers, dependingon the size of the graft, and according to preference of the user.

According to a preferred embodiment of the invention, a lockingmechanism is provided that holds the trigger in the position shown inFIG. 3 when the graft is deployed as shown in FIG. 3 and FIG. 4. Asshown in the drawing figures, the end of the actuator, or a device thatis a slidable communication with the actuator, engages a spring biasedand pivoting member 28 that engages and holds the trigger and actuator,relative to the handle and muzzle, in a locked position. In thisembodiment, a notch 30 at the end of the actuator causes the lockingmechanism to rotate due to spring biasing 34, engaging the locking lug32 with the notch, and preventing the trigger from rotating from theposition shown in FIG. 3. Once the graft is positioned, it is notnecessary for the surgeon or other operator to hold the trigger to keepthe graft in the position shown in FIG. 4 or FIG. 9 while suturing thegraft. The thumb control 36 allows the locking lug to be rotated in theopposite position and away from the notch, to again allow the trigger tobe moved back to the position of FIG. 1. This movement causes theactuator to be pulled within the muzzle of the housing, returning theflexible fingers to the position shown in FIG. 2.

At or near a distal end of the flexible fingers, a connector 40 isprovided for connecting the graft to each of the flexible fingers. Thisconnection may be controlled by control rod 42.

In the embodiment shown in FIG. 5, FIG. 6 and FIG. 7, the connector isformed in a wire. The connector may be formed in a portion of aconnector wire 50, such as a distal end of the wire, coiled to form apigtail. The connector wire may be nitinol wire than has the pigtailshape imparted as shape memory, but is sufficiently deformable with lowlevels of force applied so as to allow the connector wire to beconnected and disconnected from the graft. One connector wire ispreferred to be associated with each flexible finger. The connector wireis present in a lumen of the hollow cable from which the flexiblefingers are formed in a preferred embodiment, and the wire may bemanipulated within the lumen. The plurality of connector wires are inturn connected at a proximal end to a control rod 42.

A preferred method of attaching the graft to the flexible fingers isdescribed. The device is preferably in the position shown in FIG. 3. Aneedle 52 may be attached over the end of the connector wire as shown inFIG. 5. The needle may be slotted for attachment to the wire. The needleis used to straighten the pigtail. The needle is pushed through thegraft, delivering the pigtail to the opposite, distal, side of thegraft. FIG. 6. The needle is then pushed from the end of the connectorwire, allowing the pigtail connector to remain on the distal side of thegraft. FIG. 7. The graft is connected to the flexible arms by abuttingthe pigtail connector on one side and the flexible arm on the other.This process is repeated for each of the flexible arms.

To remove the pigtail connectors, the control rod 42 is used to pull theconnectors through the graft to the operator or proximal side of thegraft. Disconnection of the flexible fingers from the graft willtypically occur after the graft is sutured in place, and the device isin the position shown in FIG. 9. The control rod pulls the pigtailconnector through the graft. The pigtail connector is sufficientlydeformable to be straightened enough by the pulling action through thegraft so as to disconnect from the graft.

After attachment of the graft, the actuator is positioned fully towardthe handle, so that the device is in the position shown in FIG. 1. Thesheath 6 aids in folding the graft. The graft may be folded within theinterior of the plurality of flexible fingers (FIG. 2b ) or outside ofthe flexible fingers (FIG. 2a ), and the sheath protects the graft innormal handling, and as the device is inserted through a port, such astrocar 44. The sheath may be a sleeve that is slidable to be advancedaway from the handle, or retracted toward the handle, to reveal, or tocover and protect, the graft as required. The sheath may be formed tovarious shapes and sizes and geometries, such as conical and cylindricalshapes, to accommodate grafts of various sizes, shapes andconfigurations. The sheath may be split longitudinally along a side ofthe sheath, so that it can be removed from the device, or positionedover the device, even when the graft is deployed. Alternatively, a crosssection of the sheath may be C-shaped, or less than annular, tofacilitate removal and replacement of the sheath.

When the graft is in the position shown in FIG. 9, and is ready to besecured, all elements of the device for delivery of the graft forattachment to tissue are present on an operator side of the graft, withthe flexible fingers forming the radial array. Of necessity, a smallportion of the connector(s) may be extend through the graft to thedistal side of the graft; however, the elements of the device are on theproximal side, so that it is not necessary to form a hole or void in thegraft for positioning a bolster or other support device.

FIG. 10, FIG. 11 and FIG. 12 show another embodiment of the connectorformed of wire. The connector 54 may be formed in a portion of aconnector wire 50, such as a distal end of the wire, formed as a loop.The connector may be nitinol wire than has the loop imparted as shapememory, but is sufficiently deformable with low levels of force appliedso as to allow the connector wire to be connected and disconnected fromthe graft. One connector is preferred to be associated with eachflexible finger. The connector passes from the lumen of the hollowcable, through the graft, and back into the lumen of the cable. Thewires 50 are connected at a proximal end to control rod 42 as describedabove. The connectors 54 are removed from the graft after the graft isinstalled, with control rod 42 used to pull the connectors through thegraft to the proximal side of the graft. FIG. 12.

In use, according to one embodiment, a section of graft of appropriatesize to repair the subject hernia is selected and/or formed. The graftmay be formed (of various biological materials or, synthetic materials,including, but not limited to polypropylene or polytetrafluoroethylene(PTFE). The graft is connected near its perimeter to the connectors nearthe distal ends of the flexible fingers. Each flexible finger ispreferred to have a connector. The actuator is moved to the positionshown in FIG. 1, with the flexible fingers positioned generally parallelto the axis of travel of the actuator. This essentially folds the graftso that it is held as shown in shown in FIG. 2a , which is similar to afolded parachute configuration. The graft may also be positioned partlyor wholly within the flexible fingers, as shown in FIG. 2 b.

An incision is made at the approximate center of the defect. FIG. 8.Trocar 44 or trocar 60 is inserted through the incision. The device istherefore inserted through the approximate center of the defect. FIG.19. The trocar provides a port for entry of the device of the invention,and the device is inserted through the trocar. The sheath 6 covers thegraft at this point in the process, retarding the graft from catching orsnagging on the entry port, such as the trocar. The sheath may beslidable relative to the actuator. The locking mechanism holds theflexible fingers and the graft in this position.

After the distal end of the device is inserted through the incision andsufficient clearance is present, the sheath is pulled toward theoperator, or is removed, and the trigger 16 of the device is moved fromthe position of FIG. 1 to the position of FIG. 3, causing the actuatorto push the flexible fingers and associated graft to the position shownin FIG. 9 and FIG. 19. The graft is pulled up against the tissue, bymeans of the handle, to cover the hernia defect. The graft is securedusing a device 48 as determined by the surgeon, and near the perimeterof the graft area. As shown in FIG. 9, graft attachment may be providedby known methods of attachment of grafts. The procedure may be monitoredby use of a laparoscope for proper positioning, and securing, of thegraft.

The graft is formed to generally a planar form when the flexible fingersform the radial array. As noted, the fingers may move through an arcthat is more than 90°. Therefore, the surface of the graft may besomewhat curved or non-planar, so that the edges or periphery of thegraft is pushed against the tissue 80 and secured to the tissue to coverthe defect. However, the mesh is still considered to be in a generallyplanar position as shown in FIG. 4, FIG. 9 and FIG. 19.

After the connectors are released from the graft, the locking controlbutton rotates the locking lug from engagement with the actuator, andthe trigger is used to pull the actuator toward the handle, causing theflexible fingers to return to the position shown in FIG. 2. The devicemay now be removed by pulling it out of the trocar.

The flexible fingers, by being flexible along their length, with nopreformed angles, kinks or similar geometry, are sufficiently flexibleto follow a path of retreat from the fully extended position of FIG. 4to the position shown in FIG. 2, without disrupting the sutured graft,while also being sufficiently rigid to support the graft for positioningand securement at the defect site. If the flexible fingers were rigid,or contained preformed angles, the path of retreat would be dictated bysuch structure, and would prevent orderly and non-disruptive withdrawalof the device and the trocar from the surgical site.

FIGS. 13 through 16 depict a unique and novel trocar 60 that is usefulwith the delivery device and method described herein. The trocar is alsouseful in other medical procedures in which trocars are used.

In one embodiment, the trocar comprises an inner sleeve 62 and an outersleeve 64. In the embodiment as shown, the inner sleeve forms an upperportion of the trocar, while the outer sleeve forms a lower portion ofthe trocar. The inner sleeve is slidably adjustable, or telescoping,relative to the outer sleeve. The overall height of the trocar may beadjusted as preferred or required by way of the slidable, telescopingfeature. A frictional fit between the inner sleeve and the outer sleeveaccording to one embodiment allows the inner sleeve to move up or downrelative to the outer sleeve. However, the inner sleeve remains inposition relative to the outer sleeve, due to the frictional fit betweenthe inner sleeve and the outer sleeve.

The inner sleeve may comprise a head 66 that is fixed to a neck of theinner sleeve. In the embodiment as shown, the head has an opening 68 inthe top portion thereof that allows vertical access to the inner lumen72 of the trocar. The head may have a valve 70 therein. Medical devices,such as the delivery device described herein, may enter the lumen of thetrocar 60 through the valve. The valve permits the device to passthrough the valve, but the valve may be constructed to close around theperiphery of the device in the event gas for insufflation is employed.Materials, such as gas for insufflations, or liquids, may pass throughthe valve and into the lumen, but the valve resists the material fromback-flowing out of a body cavity and through the valve.

The head may also have one (1) or more ports 74, as preferred orrequired. The ports may be used for transferring devices, or morecommonly, materials, such as gases or liquids, into the lumen of thetrocar and subsequently, into a body cavity.

In a preferred embodiment, the head is removably attached to the trocar60. An O-ring 76 may be used to seal the mating surfaces of the head tothe inner sleeve of the trocar.

The lower sleeve may comprise an upper bolster in an embodiment of thetrocar 60. The upper bolster 84 may be formed of a resilient material.The upper bolster limits travel of the trocar into the body cavity, andrests against the skin of the patient to help hold the trocar inposition. The upper bolster may be formed to a permanent form, or theupper bolster may be formed of an inflatable material, and becollapsible so that the upper bolster does not interfere with furthertravel of the trocar 60 into a body cavity. If the bolster isinflatable, an access port 92 for inflation of the upper bolster may beprovided.

The outer sleeve is also preferred to comprise an inflatable stabilizingmember, or balloon 86. The inflatable stabilizing balloon iscollapsible, so that travel of the trocar through layers of skin,muscle, or other tissue is not materially inhibited by the balloon.

The balloon is inflatable after the trocar is in position. A conduit 88provides communication between the balloon and a port 90 that extendsfrom the outer sleeve, as shown in the preferred embodiment of thedrawing figures. Pressurized gas, such as nitrogen, may be used toinflate the balloon to a pressure that expands the balloon, byconnecting a gas source to the port. The gas is transported through theconduit and into the balloon to inflate the balloon. In anotherembodiment, an air filled syringe may be used to inflate the balloon.

The inner sleeve may be sloped or stepped 96 at an upper portion thereofto allow a relatively large opening, while also providing a funnel. Therelatively larger opening also allows a head of sufficient size to beattached to the device.

In use, according to the embodiment as shown, the balloon 86 isdeflated. The inner and outer sleeves are positioned as desired relativeto each other through the slidable, telescoping feature of the device.The outer sleeve is pushed into the body cavity until the bolster restsagainst the skin of the patient. The stabilizing balloon is inflated,with the stabilizing balloon inside the body cavity and the bolsterpositioned outside the body cavity. The bolster and the balloon arespaced apart so that skin, muscle and other tissue is positioned betweenthe bolster and the balloon as shown in FIG. 18. The bolster may beinflated through the access port if required. The trocar is now inposition for use with a medical device, such as the delivery devicedescribed above, and/or the measuring device as described herein, orwith other devices, or as a transport conduit for materials, includingliquids and gasses

FIGS. 17 and 18 show a measuring device 100 that is useful with thedelivery device described herein. The measuring device may be utilizedby placement through the trocar 60 as described herein. The measuringdevice may be used with some trocars previously known and used.

As shown in FIG. 17, the measuring device comprises a scale 102 and atrocar 104. The trocar 104 has a central lumen running generally throughthe central axis of the trocar 104. The trocar 104 may be deliveredthrough the trocar 60 depicted in FIGS. 13-16 and described herein. Thetrocar 104 may have a handle 106 for positioning the trocar. Themeasuring scale is formed in an elongated structure. The elongatedstructure presents indicia at defined intervals. For example, theindicia may be a series of marks at equally spaced intervals, such as 1cm. Alternatively, color bands of a particular, and defined width, suchas 1 cm, may be provided. The color bands may be individually colorcoded. The indicia, such as the color bands, are viewable with alaparoscope.

The measuring scale is preferred to be formed of shape memory material.The shape memory material permits the measuring scale 102 to betransitioned from a generally vertical position to a generallyhorizontal position as shown in FIG. 17. Bending of the measuring scaleis achieved by the lumen of the trocar 104, which is generally verticalfor most of the length of the trocar as shown in FIG. 17, buttransitions, by means of a generally horizontal exit port in the trocar,through use of an arcuate bend or an elbow 108 in the lumen. The bend orelbow may be angled to achieve a 90° turn of the measuring scale fromthe entrance to the trocar to the exit from the port of the trocar 104,but the turn could be any angle that is suitable for the particularsurgical procedure, such as 80°, 100°, 110° or 120°, or other valueswithin that range.

In one embodiment, a bulb 112 formed in a lower end of the trocar 104allows the measuring scale to travel though a larger arc prior toexiting the port in the trocar 104. This prevents the measuring scalefrom making a hard, substantially right angle, turn and allows thedevice to travel smoothly and cleanly through the lumen.

A blade 110 may be formed in a lower end of the trocar 104. The bladeallows the surgeon or other operator to pierce tissue to introduce thetrocar into the body. The scale does not extend from the trocar duringthe process of piercing tissue.

In a preferred embodiment, the measuring device is used to measure theappropriate size for the graft or synthetic mesh. The trocar ispositioned and stabilized as shown in FIG. 18, through use of thebolster 84 and the balloon 86. The measuring device is then insertedinto the trocar 60, so that a lower end of the trocar 104 issubstantially even with the defect. The measuring scale 102 is retractedinto its trocar during the delivery of the trocar 104 through the trocar60.

After the trocar 60 is in position as shown in FIG. 18, the measuringscale is pushed from above until it extends out of the port of thetrocar. The surgeon monitors the progress of the measuring scale, suchas with a laparoscope. When the measuring scale is properly positionedrelative to the defect, the operator reads the gauge markings or indiciaat the upper end of the scale. By determining how far the measuringscale has advanced, and reading the markings or indicia that are exposedat the upper end of the trocar, the surgeon determines the proper radiusor size of the graft or mesh that will be required for the repairprocedure as described above. The measuring scale may be rotatedrelative to the trocar, up to 360°. The measuring scale may be rotatedin a sweeping motion relative to the defect, so that measurements aretaken at multiple points of the defect. After the surgeon determines apreferred size of mesh or graft to be deployed using the deliverydevice, the graft is attached as described herein to the delivery deviceand the repair procedure is performed using the delivery device asdescribed above.

The measuring device is useful in other applications where measurementsinternal to the body, such as a body cavity, are desirable.

What is claimed is:
 1. A device for delivery of a graft for attachmentto tissue, comprising: a plurality of spaced apart, flexible fingers; aplurality of control wires, wherein each of the control wires isconnected to one of the flexible fingers at a distal end of the controlwires; an actuator, wherein the actuator is movable outwardly relativeto a handle, and the plurality of flexible fingers are in communicationwith, and move in response to movement of the actuator; wherein,proximal ends of the control wires are in a fixed position relative tomovement of the flexible fingers as the flexible fingers and theactuator move outwardly relative to the handle, causing the controlwires to exert a force on the flexible fingers and pull the flexiblefingers as deployed by the actuator into a radial array.
 2. A device fordelivery of a graft for attachment to tissue as described in claim 1,wherein the plurality of flexible fingers travel through a range ofmotion of more than 90 degrees from an axis of travel of the actuator toform the radial array.
 3. A device for delivery of a graft forattachment to tissue as described in claim 1, wherein the plurality offlexible fingers are formed of flexible cable.
 4. A device for deliveryof a graft for attachment to tissue as described in claim 1, wherein theplurality of flexible fingers are formed of flexible cable, and theflexible cable is hollow, coiled cable.
 5. A device for delivery of agraft for attachment to tissue as described in claim 1, wherein aconnector of the plurality of flexible fingers is constructed andarranged to connect to a graft.
 6. A device for delivery of a graft forattachment to tissue as described in claim 1, further comprising a graftfor attachment to tissue and a plurality of connectors, with oneconnector of the plurality of connectors positioned near a distal end ofeach of the flexible fingers, wherein the connectors are constructed andarranged to connect to the graft.
 7. A device for delivery of a graftfor attachment to tissue as described in claim 1, further comprising agraft, wherein all elements of the device for delivery of the graft forattachment to tissue are present on an operator side of the graft whenthe flexible fingers form the radial array.
 8. A device for delivery ofa graft for attachment to tissue as described in claim 1, furthercomprising a graft, wherein the graft is arranged to a generally planarform when the flexible fingers form the radial array.
 9. A device fordelivery of a graft for attachment to tissue as described in claim 1,wherein the actuator is movable toward the handle, and as the actuatormoves toward the handle, the plurality of flexible fingers moves fromthe radial array and upwardly towards the axis of travel of the actuatoras the actuator moves toward the handle.
 10. A device for delivery of agraft for attachment to tissue as described in claim 1, furthercomprising a sheath that covers the plurality of flexible fingers, andthe plurality of flexible fingers exit at a distal end of the sheathwhen the plurality of flexible fingers are moved outwardly from thehandle to form the radial array.
 11. A device for delivery of a graftfor attachment to tissue as described in claim 1, further comprising asheath, wherein the actuator is movable toward the handle to move theplurality of flexible fingers to a position that is generally parallelto an axis of travel of the actuator, wherein the plurality of flexiblefingers is positioned within the sheath when the actuator is fully movedtoward the handle.
 12. A device for delivery of a graft for attachmentto tissue as described in claim 1, further comprising a sheath, whereinthe sheath is advanced away from and retracted toward the handle, andwherein the sheath covers the flexible fingers when the sheath advancesaway from the handle and the sheath reveals the flexible fingers whenthe sheath is retracted toward the handle.
 13. A device for delivery ofa graft for attachment to tissue as described in claim 1, furthercomprising a sheath, wherein the sheath is advanced away from andretracted toward the handle, and wherein the sheath covers a graft thatis connected to the flexible fingers when the sheath advances away fromthe handle and the sheath reveals the graft when the sheath is retractedtoward the handle.
 14. A device for delivery of a graft for attachmentto tissue as described in claim 1, further comprising a sheath, whereinthe sheath is advanced away from and retracted toward the handle, andwherein the sheath folds a graft that is connected to the flexiblefingers within the sheath when the sheath advances away from the handle,and the sheath reveals the graft when the sheath is retracted toward thehandle.
 15. A device for delivery of a graft for attachment to tissue asdescribed in claim 1, wherein a graft is connected to the device by aplurality of wires that extend from the plurality of flexible fingers.16. A device for delivery of a graft for attachment to tissue asdescribed in claim 1, wherein a graft is connected to the device by aplurality of wires that extend from the plurality of flexible fingers,wherein the wires are formed of shape memory material.
 17. A device fordelivery of a graft for attachment to tissue as described in claim 1,further comprising a trocar, wherein the trocar comprises an outersleeve and an inner sleeve, wherein the outer sleeve is positioned over,and is slidable relative to the inner sleeve, and wherein a lumenextends through both the outer sleeve and the inner sleeve, wherein thelumen opens at a top and a bottom of a construct formed by the outersleeve and the inner sleeve, and the lumen extending through the outersleeve communicates with the lumen extending through the inner sleeve.18. A device for delivery of a graft for attachment to tissue asdescribed in claim 1, further comprising a trocar, wherein the trocarcomprises a lumen extending from an upper portion to a lower portionthereof and further comprising a measuring scale, said measuring scalehaving measurement indicia thereon, said measuring scale extendingthrough said lumen and out of a lower portion of the lumen, wherein themeasuring scale is formed of shape memory material, and a length of themeasuring scale is deformed by the trocar as the measuring scaletraverses the trocar, and the measuring scale assumes a generallystraight configuration upon exit from the lower portion of the lumen ofthe trocar.
 19. A device for delivery of a graft for attachment totissue as described in claim 1, further comprising a trocar, wherein thetrocar comprises a lumen extending from an upper portion to a lowerportion thereof and further comprising a measuring scale, the measuringscale having measurement indicia thereon, said measuring scale extendingthrough the lumen and out of a lower portion of the lumen, wherein anangle of exit of the measuring scale from the lumen is 80° to 120°wherein the measuring scale is formed of shape memory material, and alength of the measuring scale is deformed by the trocar as the measuringscale traverses the trocar, and the measuring scale assumes a generallystraight configuration upon exit from the lower portion of the lumen ofthe trocar.
 20. A device for delivery of a graft for attachment totissue as described in claim 1, further comprising a trocar, wherein thetrocar comprises a lumen extending from an upper portion to a lowerportion thereof and further comprising a measuring scale, the measuringscale having measurement indicia thereon, said measuring scale extendingthrough the lumen and out of an upper portion of the lumen and out of alower portion of the lumen, wherein an angle of exit of the measuringscale from the lumen is 80° to 120° from an angle of entry of themeasuring scale into the lumen, and wherein the measuring scale isformed of shape memory material and, wherein the measuring scale isformed of shape memory material, and a length of the measuring scale isdeformed by the trocar as the measuring scale traverses the trocar, andthe measuring scale assumes a generally straight configuration upon exitfrom the lower portion of the lumen of the trocar, and the measuringscale is positioned at an angle of 80° to 120° from the angle of entryof the measuring scale into the lumen.
 21. A device for delivery of agraft for attachment to tissue as described in claim 1, furthercomprising a first trocar, wherein the first trocar comprises an outersleeve and an inner sleeve, wherein the outer sleeve is positioned over,and is slidable relative to the inner sleeve, and wherein a lumenextends through both the outer sleeve and the inner sleeve, wherein thelumen opens at a top and a bottom of a construct formed by the outersleeve, and the lumen extending through the outer sleeve communicateswith the lumen extending through the inner sleeve, and the inner sleevefurther comprising a second trocar that is present in the lumen of thefirst trocar, wherein the second trocar comprises a lumen extending froman upper portion to a lower portion thereof and further comprising ameasuring scale, said measuring scale having measurement indiciathereon, said measuring scale extending through said lumen and out of alower portion of the lumen.
 22. A device for delivery of a graft forattachment to tissue as described in claim 1, wherein the plurality offlexible fingers are mounted in a holder, and wherein the plurality offlexible fingers are rotatable relative to the holder.
 23. A device fordelivery of a graft for attachment to tissue as described in claim 1,wherein each of the plurality of flexible fingers is constructed tocomprise a variable length.
 24. A device for delivery of a graft forattachment to tissue as described in claim 1, wherein a proximal end ofeach of the control wires is mounted to an article that is associatedwith the handle and is stationary relative to the actuator.
 25. A devicefor delivery of a graft for attachment to tissue as described in claim1, wherein a proximal end of each of the control wires is mounted to thedevice and constructed and arranged so that the proximal end of each ofthe control wires does not move as the actuator moves.
 26. A device fordelivery of a graft for attachment to tissue as described in claim 1,wherein the distal end of a control wire is attached to a flexiblefinger at a point that is less than 25% of a distance along a length ofthe flexible finger, as measured from the joinder of a proximal end ofthe flexible fingers to the distal end of the flexible finger.
 27. Adevice for delivery of a graft for attachment to tissue as described inclaim 1, wherein an acute angle of 30° to 60° degrees is formed by thecontrol wires relative to the flexible fingers when the actuator isfully advanced.
 28. A device for delivery of a graft for attachment totissue as described in claim 1, further comprising a trocar, wherein thetrocar comprises a lumen extending from an upper portion to a lowerportion thereof and further comprising a measuring scale, said measuringscale having measurement indicia thereon, said measuring scale extendingthrough said lumen and out of a lower portion of the lumen, wherein themeasuring scale is formed of shape memory material, and a length of themeasuring scale is deformed to an arcuate shape by the trocar as themeasuring scale traverses the trocar, and the measuring scale assumes agenerally straight configuration upon exit from the lower portion of thelumen of the trocar.